Quality Engineer

Job description

• Support quality assurance programmes, procedures, and controls for medical devices and finished goods.
• Review, plan, coordinate, and implement change controls while assessing quality and regulatory impact.
• Collaborate with Manufacturing Engineering and Operations teams on risk assessments, process improvements, and quality initiatives.
• Lead and support investigations relating to non-conformances, CAPAs, and quality system issues.
• Conduct root cause analysis and implement effective corrective and preventive actions.
• Monitor quality performance trends and utilise statistical tools to identify improvement opportunities.
• Support validation activities, including strategy development, sampling plans, and execution for new and existing product lines.
• Ensure compliance with ISO 13485, Quality Management Systems (QMS), and applicable regulatory requirements.
• Identify potential quality and compliance risks and support mitigation activities.
• Drive continuous improvement projects to enhance operational efficiency and maintain regulatory compliance.
• Work closely with Supply Chain, Operations, and Engineering teams to ensure effective quality oversight.

• Bachelor’s Degree in Engineering, Science, or a related discipline.
• 3-5 years’ experience within a regulated Medical Device environment.
• Strong working knowledge of ISO 13485 and Quality Management Systems (QMS).
• Experience managing change controls, CAPA investigations, and non-conformance processes.
• Knowledge of risk management methodologies, including FMEA (Failure Mode and Effects Analysis).
• Experience with root cause analysis and structured problem-solving techniques.
• Strong communication skills with the ability to present technical information to both technical and non-technical stakeholders.
• Proficient in Microsoft Office applications, including Excel, Word, and PowerPoint.